PharmacofMRI of Anxiolytic Medications (Pregabalin)

NCT00706836 | Completed Phase 4 Results

• 2 other identifiers: UCSD IRB 060407 - BR01MH075792
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to use functional magnetic resonance imaging (fMRI) in healthy controls to examine the acute effects of certain anxiolytic medications on brain function. In this case, the medication pregabalin will be used. The investigators hypothesize that pregabalin (at doses of 50 mg and 200 mg, versus placebo) will yield a reduction in amygdala and insula activity (in a dose-dependent fashion) during emotion processing using fMRI.

Conditions

Anxiety Disorders

Keywords

anxiety; functional magnetic resonance imaging; fMRI; pregabalin; Lyrica

Outcome Measures

Primary Outcomes (1)

• Effect of Pregabalin (Two Doses) Versus Placebo

  Region of Interest (ROI) analysis of contrast of doses (high and low) of pregabalin vs placebo on brain activity at rest and during emotional stimuli using fMRI and clinical scales.

  Week 1, 2, 3 (Cross-over Design)

Study Arms (3)

Pregabalin 50 mg

ACTIVE COMPARATOR

Pregabalin oral tablets (50 mg)

Drug: Pregabalin 50mg

Pregabalin 200 mg

ACTIVE COMPARATOR

Pregabalin oral tablets (200 mg)

Drug: Pregabalin 200 MG

Placebo

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

Pregabalin 50mg DRUG

One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan

Also known as: Lyrica

Pregabalin 50 mg

Pregabalin 200 MG DRUG

One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan

Also known as: Lyrica

Pregabalin 200 mg

placebo DRUG

One dose of matched oral placebo to be administered one hour prior to fMRI scan

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male, or female (not pregnant or intending to become pregnant during the study)
• Between the ages of 18-30.
• In good general health.
• No specific contraindications to the drug being administered

You may not qualify if:

• Subjects with a history of DSM-IV depressive disorder, psychotic disorder, anxiety disorder
• Subjects who meet criteria for substance abuse or dependence within the last 6 months
• Subjects with an positive urine screen for illicit drugs having clinically significant abnormal laboratory, ECG or physical examination findings not resolved by the baseline visit
• Patients who have taken psychotropic drugs or antidepressants (including monoamine oxidase inhibitors, MAOI's) within the last year
• Subjects who are left-handed.
• Subjects suffering suffers from claustrophobia, or phobia for injections or blood

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92037, United States

Location

Related Publications (1)

• Aupperle RL, Ravindran L, Tankersley D, Flagan T, Stein NR, Simmons AN, Stein MB, Paulus MP. Pregabalin influences insula and amygdala activation during anticipation of emotional images. Neuropsychopharmacology. 2011 Jun;36(7):1466-77. doi: 10.1038/npp.2011.32. Epub 2011 Mar 23.

  PMID: 21430645 RESULT

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Murray B. Stein MD, MPH
• Organization: University of California San Diego

mstein@ucsd.edu

858-534-6400

Study Officials

• Murray B Stein, MD, MPH

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 26, 2008
• First Posted: June 30, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: April 9, 2019
• Results First Posted: December 22, 2014

Record last verified: 2019-04

Locations

US (1)